(270 days)
BMC Willow Mask, K112277
No
The device description and performance studies focus on the physical characteristics and airflow mechanics of the masks, with no mention of AI or ML.
No
The device is a mask that channels airflow from a positive airway pressure device to a patient. It is an accessory to a therapeutic device (CPAP or bi-level system), but not a therapeutic device itself as it does not actively treat a medical condition.
No
These devices (Viva Nasal Mask and Numa Full Face Mask) are designed to channel airflow to a patient from a positive airway pressure device (like CPAP or bi-level systems), serving as an interface for therapy. They do not collect or analyze medical data to diagnose a condition.
No
The device description clearly details physical components like plastic bodies, silicone seals, and headgear, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the masks "channel airflow noninvasively to a patient from a positive airway pressure device". This describes a device used for delivering therapy (positive airway pressure), not for examining specimens from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description focuses on the physical components of the mask and how it interfaces with the patient's face to deliver airflow. There is no mention of analyzing biological samples.
- Performance Studies: The performance studies described are related to the physical and functional performance of the mask in delivering airflow and ensuring patient safety (e.g., CO2 rebreathing, anti-asphyxia valve performance, pressure-flow characteristics). These are not studies related to the analytical or clinical performance of an IVD.
- Lack of IVD Characteristics: There is no mention of reagents, calibrators, controls, or any other components typically associated with IVD devices.
In summary, the Viva Nasal Mask and Numa Full Face Mask are medical devices used for delivering respiratory therapy, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
The Viva Nasal Mask channels airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bi-level system.
The Viva Nasal Mask is:
To be used by adult patients (>66lbs />30kg) for whom positive airway pressure has been prescribed.
Intended for single-patient reuse.
The Numa Full Face Mask channels airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or Bi-level system.
The Numa Full Face Mask is:
To be used by adult patients (>66lbs / >30kg) for whom positive airway pressure has been prescribed.
Intended for single-patient reuse.
Product codes (comma separated list FDA assigned to the subject device)
BZD
Device Description
Viva Nasal Mask provides an interface such that airflow from a positive pressure source is directed to the patient's nose. The masks are held in place with adjustable headgear that straps the mask to the face. Viva Nasal Mask has plastic body and silicone seal that touches the face and includes a pad that rests on the forehead.
The Viva Nasal Mask is a prescription device supplied non-sterile.
Numa Full Face Mask provides an interface such that airflow from a positive pressure source is directed to the patient's mouth and nose. The masks are held in place with adjustable headgear that straps the mask to the face. Numa Full Face Mask has plastic body and silicone seal that touches the face and include an adjustable pad that rests on the forehead.
Numa Full Face Mask is a prescription device supplied non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Viva Nasal Mask: Nose
Numa Full Face Mask: Nose and mouth
Indicated Patient Age Range
Adult patients (>66lbs />30kg)
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
Performance testing was carried out in conformance with ISO 17510-2 to verify the performance of the Viva Nasal Mask and Numa Full Face Mask.
The performance bench testing includes: Passive exhalation port flow, the resistance to flow, anti-asphyxia valve related testing, dead space, CO2 rebreathing, ISO 17510-2 testing, transportation, and accelerated aging and shelf life.
Key results: The results of performance data show that the Viva Nasal Mask is substantially equivalent to its predicate mask -- BMC-NM2 Nasal Mask (K133009), and the Numa Full Face Mask is substantially equivalent to its predicate mask -- Quattro™ Air (K123979). The CO2 performance of the new device was tested to ensure the mask design provides adequate venting to flush out the expired CO2. The testing included physical and functional dead-space, measurements. The device was shown to be substantially equivalent to the predicate devices. The Anti-Asphyxia Valve (AAV) performance was tested to ensure the patient can continue to breathe fresh air if ever the airflow from the flow generator is impeded. The device was shown to be substantially equivalent to the predicate devices. The pressure-flow characteristics and through impedance of the mask were tested to ensure clinicians are able to prescribe the appropriate therapy using the new device. The device was shown to be substantially equivalent to the predicate devices. The mechanical integrity and performance of the new device was tested during normal use and reasonable abuse scenarios. The device was also tested to demonstrate that the mask can withstand the effects of storage temperature, humidity and transportation shock & vibration. All the materials used in the manufacturing of the Viva Nasal Mask and Numa Full Face Mask are identical to the materials used in BMC's legally marketed Willow Mask (K112271) under same conditions. In conclusion, the test reports demonstrate that the Viva Nasal Mask and Numa Full Face Mask are substantially equivalent to the predicate devices.
Clinical Test:
No clinical testing was performed; use of full face mask and nasal mask with CPAP or bilevel therapy is proven technology and is well accepted by the medical community.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
BMC-NM2 Nasal Mask (K133009), Quattro™ Air (K123979)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
BMC Willow Mask, K112277
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 5, 2017
BMC Medical.,Ltd. % Alex Lucio Executive Vice President 3B Medical Inc. 799 Overlook Drive. Winter Haven, F1 33884
Re: K163464
Trade/Device Name: Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: July 19, 2017 Received: July 24, 2017
Dear Alex Lucio:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Michael J. Ryan -S
for Lori A. Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K163464
Device Name
Viva Nasal Mask (Model: NM4) Numa Full Face Mask (Model: BMC-FM2)
Indications for Use (Describe)
The Viva Nasal Mask channels airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bi-level system.
The Viva Nasal Mask is:
[]To be used by adult patients (>661bs />30kg) for whom positive airway pressure has been prescribed. □Intended for single-patient reuse.
The Numa Full Face Mask channels airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or Bi-level system.
The Numa Full Face Mask is:
□ To be used by adult patients (>661bs />30kg) for whom positive airway pressure has been prescribed.
□ Intended for single-patient reuse.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
510(k) Owner:
| Name: | BMC Medical Co., Ltd. |
|---|---|
| Address: | Room 110 Tower A Fengyu Building, No. 115 |
| Fucheng Road Haidian, Beijing100036, | |
| PEOPLE'S REPUBLIC OF CHINA | |
| Phone: | 0086-010-51663880-705 |
| Fax: | 0086-010-51663880-810 |
| Contact Person: | Jiang Huiqi |
| Submission Date: | November 15, 2016 |
Submission Correspondent:
| Name: | Alex Lucio
Executive Vice President |
|----------|------------------------------------------------------------------|
| Address: | 3B Medical, Inc.
799 Overlook Drive
Winter Haven, FL 33884 |
| Phone: | 863-226-6284 |
| Email: | alucio@3Bproducts.com |
Applicant Device Information:
| Trade Name: | Viva Nasal Mask (Model: NM4)
Numa Full Face Mask (Model: BMC-FM2) |
|----------------------|----------------------------------------------------------------------|
| Common Name: | Vented Face Mask |
| Name/Classification: | Accessory to Non-Continuous
Ventilator |
| Product Code: | BZD |
| Regulation Number: | 21CFR 868.5905 |
| Device Class: | II |
| Predicate Device(s) | |
| | Predicate Device of Viva Nasal Mask: BMC-NM2 Nasal
Mask (K133009) |
| | Predicate Device of Numa Full Face Mask: Quattro™ Air
(K123979) |
4
Reference Device
BMC Willow Mask, K112277
Device Description
Viva Nasal Mask
Viva Nasal Mask provides an interface such that airflow from a positive pressure source is directed to the patient's nose. The masks are held in place with adjustable headgear that straps the mask to the face. Viva Nasal Mask has plastic body and silicone seal that touches the face and includes a pad that rests on the forehead.
The Viva Nasal Mask is a prescription device supplied non-sterile.
Numa Full Face Mask
Numa Full Face Mask provides an interface such that airflow from a positive pressure source is directed to the patient's mouth and nose. The masks are held in place with adjustable headgear that straps the mask to the face. Numa Full Face Mask has plastic body and silicone seal that touches the face and include an adjustable pad that rests on the forehead.
Numa Full Face Mask is a prescription device supplied non-sterile.
Indications for Use
The Viva Nasal Mask channels airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bi-level system.
The Viva Nasal Mask is:
- . To be used by adult patients (>66lbs />30kg) for whom positive airway pressure has been prescribed.
- Intended for single-patient reuse.
The Numa Full Face Mask channels airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or Bi-level system.
The Numa Full Face Mask is:
- To be used by adult patients (>66lbs / >30kg) for whom positive airway ● pressure has been prescribed.
- Intended for single-patient reuse. ●
5
Table 1: Technical Comparison to the Predicate Device 1.1 Comparison Table1 (Viva (Model: NM4) K163464to BMC-NM2 Nasal Mask (K133009))
| Comparison Elements | Applicant Device | Predicate Device | Comparison Statement | |
|---|---|---|---|---|
| Viva (Model: NM4)K163464 | BMC-NM2 (K133009) | |||
| Device name | Nasal Mask | Nasal Mask | ||
| Classification name | Accessory to Non-Continuous Ventilator | Accessory to Non-Continuous Ventilator | Same classification information | |
| Product code | BZD | BZD | ||
| Indications for Use | The Viva Nasal Mask channels airflow | |||
| noninvasively to a patient from a positive | ||||
| airway pressure device such as a continuous | ||||
| positive airway pressure (CPAP) or bi-level | ||||
| system. | ||||
| The Viva Nasal Mask is: | ||||
| To be used by adult patients (>66lbs | ||||
| / >30kg) for whom positive airway pressure | ||||
| has been prescribed. | ||||
| Intended for single-patient reuse. | The BMC-NM2 Nasal Mask channels airflow | |||
| noninvasively to a patient from a positive | ||||
| airway pressure device such as a continuous | ||||
| positive airway pressure (CPAP) or Bi-level | ||||
| system. | ||||
| The BMC-NM2 Nasal Mask is: | ||||
| To be used by adult patients (>30 kg) for whom | ||||
| positive airway pressure has been prescribed. | ||||
| Intended for single-patient re-use in home | ||||
| environment and multi-patient reuse in the | ||||
| hospital/institutional environment. | Different. | |||
| The inclusion of "single-patient reuse" is | ||||
| a narrower indication to the "multi- | ||||
| patient, multi-use" in the hospital / | ||||
| institutional environment | ||||
| and does not alter the intended | ||||
| use of the device. | ||||
| Target population | Adult (>66lbs / >30kg) | Adult (>66lbs/30kg) | Same | |
| Patient usage type | Single-patient reuse | Single-patient reuse in home environment and | ||
| multi-patient reuse in the hospital/institutional | ||||
| environment. | Different. | |||
| The inclusion of "single-patient reuse" is | ||||
| a narrower indication to the "multi- | ||||
| patient, multi-use" in the hospital / | ||||
| institutional environment | ||||
| and does not alter the intended | ||||
| use of the device. | ||||
| Anatomical site | Nose | Nose | Same | |
| Provided sterile or non-sterile | Not sterile | Not sterile | Same | |
| Design | Nasal interface and headgear | Nasal interface and headgear | Same | |
| Number of mask size | Three sizes (small, medium, and large) | Three size (small, medium, and large) | Same | |
| Patient circuit connection | 22mm entrainment valve elbow | 22mm entrainment valve elbow | Same | |
| Therapy Pressure range | 4 to 25 hPa | 4 to 30 hPa | Different. | |
| This difference will not raise new risks, | ||||
| as pressure range is within subset o | ||||
| predicate. | ||||
| Device | ||||
| Specifica | ||||
| tions | ||||
| Comparison Elements | Applicant Device | |||
| Viva (Model: NM4)K163464 | Predicate Device | |||
| BMC-NM2 (K133009) | Comparison Statement | |||
| Intentional leak(Passive | ||||
| Exhalation Port Flow) | 4hPa=19 L/min | |||
| 8hPa=28L/min | ||||
| 12hPa=35L/min | ||||
| 16hPa=41L/min | ||||
| 20hPa=46L/min | ||||
| 25hPa=51L/min | 4hPa=20L/min | |||
| 12hPa=40L/min | ||||
| 20hPa=51L/min | ||||
| 30hPa=72L/min | Different. | |||
| International leak is actually to exhale CO2. Under the same pressure, subject | ||||
| device's intentional leak is slightly | ||||
| smaller than that of predicate device. This | ||||
| difference has little impact on CO2 | ||||
| rebreathing. The subject device has | ||||
| passed CO2 rebreathing testing according | ||||
| to ISO 17510-2:2007. Please refer to | ||||
| "Appendix E_CO2 Rebreathing Testing". | ||||
| Hence, this difference will not introduce | ||||
| any additional risk to the user. | ||||
| Dead space | S Size: 76ml | |||
| M Size: 83ml | ||||
| Large Size: 92ml | S Size: 124ml | |||
| M Size: 129ml | ||||
| Large Size: 135ml | Different. | |||
| The dead space of three sizes is less than | ||||
| that of the predicate. | ||||
| All seal sizes are in conformance with | ||||
| ISO 17510-2:2007 and this difference | ||||
| does not introduce any additional risk to | ||||
| the user. | ||||
| Resistance/ | ||||
| Pressure Drop | at 50L/min: 0.2 hPa | |||
| at 100L/min: 0.8 hPa | at 50 L/min: 0.2 hPa | |||
| at 100 L/min: 0.5 hPa | Same. | |||
| Operating environment | 5 to 40°C | |||
| 10% to 93% relative humidity, non-condensing | 5 to 40°C | |||
| 10% to 93% relative humidity, non-condensing | Same. | |||
| Storage environment | -20 to +55°C | |||
| 10% to 93% relative humidity, non-condensing | -20 to +55°C | |||
| 10% to 93% relative humidity, non-condensing | Same. | |||
| Materials | Polycarbonate | |||
| Silicon | Polycarbonate | |||
| Silicon | Same materials for BMC's Willow Nasal | |||
| Mask (K112271) Cleared previously for | ||||
| substantially equivalent intended use. | ||||
| Comparison Elements | Applicant Device | Predicate Device | Comparison Statement | |
| Viva (Model: NM4)K163464 | BMC-NM2 (K133009) | |||
| Nylon & Spandex Fabric | Nylon & Spandex Fabric | |||
| Polypropylene | — |
6
7
1.2 Comparison Table 2 (Numa (Model: BMC-FM2) K163464 to Quattro™Air(K123979))
| Comparison Elements | Applicant Device | Predicated Device | Conclusion | |
|---|---|---|---|---|
| Device name | Numa (Model: BMC-FM2)K163464 | |||
| Full Face Mask | QuattroTMAir(K123979) | |||
| Full Face Mask | ||||
| Classification name | Accessory to Non-Continuous Ventilator | Accessory to Non-Continuous Ventilator | Same classification information | |
| Product code | BZD | BZD | ||
| Indications for Use | The Numa Full Face Mask channels airflow | |||
| noninvasively to a patient from a positive | ||||
| airway pressure device such as a continuous | ||||
| positive airway pressure (CPAP) or Bi-level | ||||
| system. | ||||
| The Numa Full Face Mask is: | ||||
| To be used by adult patients (>66lbs / >30kg) | ||||
| for whom positive airway pressure has been | ||||
| prescribed. | ||||
| Intended for single-patient reuse. | The Quattro Air is a noninvasive accessory used | |||
| for channeling airflow (with or without | ||||
| supplemental oxygen) to a patient from a positive | ||||
| airway pressure (PAP) device such as a | ||||
| continuous positive airway pressure (CPAP) or | ||||
| bilevel system. | ||||
| The Quattro Air is: | ||||
| to be used by patients (weighing >30 kg) for | ||||
| whom positive airway pressure therapy has been | ||||
| prescribed | ||||
| intended for single-patient reuse in the home | ||||
| environment and multipatient reuse in the | ||||
| hospital/institutional environment.. | Different. | |||
| The inclusion of "single-patient | ||||
| reuse" is a narrower indication to | ||||
| the "multi-patient, multi-use" in the | ||||
| hospital / institutional environment | ||||
| and does not alter the intended | ||||
| use of the device. | ||||
| Target population | Adult (>66lbs / >30kg) | Adult (>66lbs/30kg) | Same | |
| Patient usage type | Single-patient reuse | Single-patient re-use in the home environment and | ||
| multi-patient re-use in the hospital/institutional | ||||
| environment | Different. | |||
| The inclusion of "single-patient | ||||
| reuse" is a narrower indication to | ||||
| the "multi-patient, multi-use" in the | ||||
| hospital / institutional environment | ||||
| and does not alter the intended | ||||
| use of the device. | ||||
| Anatomical site | Nose and mouth | Nose and mouth | Same | |
| Comparison Elements | Applicant Device | Predicated Device | Conclusion | |
| Numa (Model: BMC-FM2)K163464 | Quattro™Air(K123979) | |||
| Provided sterile or non-sterile | Not sterile | Not sterile | Same | |
| Design | face interface and headgear | face interface and headgear | Same | |
| Number of mask size | Three sizes (small, medium, and large) | Four sizes (extra small, small, medium, and large) | Similar. The predicate is available | |
| in an additional extra small size. | ||||
| The additional size is an optional | ||||
| sizing option. That has no | ||||
| correlation to safety or | ||||
| effectiveness. | ||||
| Patient circuit connection | 22mm entrainment valve elbow | 22mm entrainment valve elbow | Same | |
| Therapy Pressure range | 3 to 40hPa | 3 to 40 hPa | Same | |
| Device Specifications | Intentional leak(Passive | |||
| Exhalation Port Flow) | 3 cm H2O =18L/min | |||
| 4 cm H2O =22 L/min | ||||
| 8 cm H2O =32 L/min | ||||
| 10 cm H2O=36 L/min | ||||
| 12 cm H2O =40L/min | ||||
| 16 cm H2O =47 L/min | ||||
| 20 cm H2O =53 L/min | ||||
| 25 cm H2O =60 L/min | ||||
| 30 cm H2O =65 L/min | ||||
| 35 cm H2O =71L/min | ||||
| 40 cm H2O =78 L/min | 3 cm H2O =19 L/min | |||
| 4 cm H2O =22 L/min | ||||
| 8 cm H2O =32 L/min | ||||
| 12 cm H2O =41 L/min | ||||
| 16 cm H2O =48 L/min | ||||
| 20 cm H2O =54 L/min | ||||
| 24cm H2O =60L/min | ||||
| 28cm H2O =66L/min | ||||
| 30 cm H2O =69 L/min | ||||
| 32cm H2O =72L/min | ||||
| 36cm H2O =72L/min | ||||
| 38cm H2O =77L/min | ||||
| 40cm H2O =82 L/min | Different. | |||
| International leak is actually to | ||||
| exhale CO2. Under the same | ||||
| pressure, subject device's | ||||
| intentional leak is slightly smaller | ||||
| than that of predicate device. This | ||||
| difference has little impact on | ||||
| CO2rebreathing. The subject device | ||||
| has passed CO2rebreathing testing | ||||
| according to ISO 17510-2:2007. | ||||
| Please refer to "Appendix E_CO2 | ||||
| Rebreathing Testing". Hence, this | ||||
| difference will not introduce any | ||||
| additional risk to the user. | ||||
| Dead space | S Size: 171ml | |||
| M Size: 192ml | ||||
| Large Size: 218mL | S Size: 176ml | |||
| M Size: 198ml | ||||
| Large Size: 222mL | Different. The dead space of three | |||
| sizes is less than that of the | ||||
| predicate. All seal sizes are in | ||||
| conformance with ISO 17510-2 | ||||
| (2007) and this difference does not | ||||
| introduce any additional risk to the | ||||
| Comparison Elements | Applicant Device | |||
| Numa (Model: BMC-FM2)K163464 | Predicated Device | |||
| Quattro™Air(K123979) | Conclusion | |||
| user. | ||||
| Resistance/ | ||||
| Pressure Drop | at 50L/min: 0.15 cm H2O | |||
| at 100L/min: 0.5 cm H2O | at 50 L/min: 0.1 cm H2O | |||
| at 100 L/min: 0.4 cm H2O | Testing is performed and results | |||
| from this testing concluded that the | ||||
| verification testing raises no new | ||||
| issues of safety or effectiveness. | ||||
| Inspiratory and expiratory | ||||
| resistance (with Anti Asphyxia | ||||
| Valve open to atmosphere) | Inspiration at 50 L/min: 1.8 cm H2O | |||
| Expiration at 50 L/min: 2.0 cm H2O | Inspiration at 50 L/min: 0.2cm H2O | |||
| Expiration at 50 L/min: 0.9 cm H2O | Different. Testing is performed | |||
| according to ISO 17510-2:2007 and | ||||
| results are all less than 10cmH2O | ||||
| required in Clause 5.5 of ISO | ||||
| 17510-2:2007. Hence, testing | ||||
| shows inspiratory and expiratory | ||||
| resistance are substantially | ||||
| equivalent . | ||||
| Operating environment | 5 to 40°C | |||
| 10% to 93 % relative humidity non-condensing | 5°C to 40°C | |||
| 15% to 95% relative humidity non-condensing | Similar. This difference will not | |||
| raise new risks. | ||||
| Storage and | ||||
| transport | ||||
| environment | -20 to +55°C | |||
| 10% to 93% relative humidity, non-condensing | -20 to +60°C | |||
| 0% to 95% relative humidity, non-condensing | Different. The labeled maximum | |||
| for storage and transport | ||||
| environment is a few degrees at the | ||||
| outside maximum. This difference | ||||
| will not raise new risks. | ||||
| Materials | Silicon | Silicon | As predicate device is manufactured | |
| Nylon & spandex Fabric | "Breathoprene" Fabric | by a different manufacturer, | ||
| formulations are unknown. | ||||
| Polycarbonate | Molded Plastic | Leveraging K112271, also | ||
| manufactured by BMC Medical, for | ||||
| Polypropylene | — | biocompatibility. The materials | ||
| used in K112271 are identical to the | ||||
| materials used in the proposed | ||||
| device. |
8
K163464 - 510(k) Summary Doc No.: BMC-TF (FDA)- NM4-FM2
9
K163464 - 510(k) Summary Doc No.: BMC-TF (FDA)- NM4-FM2
10
Performance Data
Non-Clinical Testing
Performance testing has been carried out in conformance with ISO 17510-2 to verify the performance of the Viva Nasal Mask and Numa Full Face Mask. The results of performance data show that the Viva Nasal Mask is substantially equivalent to its predicate mask -- BMC-NM2 Nasal Mask (K133009), and the Numa Full Face Mask is substantially equivalent to its predicate mask -- Quattro™ Air (K123979)
The performance bench testing includes:
Passive exhalation port flow, the resistance to flow, anti-asphyxia valve related testing, dead space, CO2 rebreathing, ISO 17510-2 testing, transportation, and accelerated aging and shelf life.
The CO2 performance of the new device was tested to ensure the mask design provides adequate venting to flush out the expired CO2. The testing included physical and functional dead-space, measurements. The device was shown to be substantially equivalent to the predicate devices. The Anti-Asphyxia Valve (AAV) performance was tested to ensure the patient can continue to breathe fresh air if ever the airflow from the flow generator is impeded. The device was shown to be substantially equivalent to the predicate devices.
The pressure-flow characteristics and through impedance of the mask were tested to ensure clinicians are able to prescribe the appropriate therapy using the new device. The device was shown to be substantially equivalent to the predicate devices. The mechanical integrity and performance of the new device was tested during normal use and reasonable abuse scenarios. The device was also tested to demonstrate that the mask can withstand the effects of storage temperature, humidity and transportation shock & vibration.
All the materials used in the manufacturing of the Viva Nasal Mask and Numa Full Face Mask are identical to the materials used in BMC's legally marketed Willow Mask (K112271) under same conditions.
In conclusion, the test reports demonstrate that the Viva Nasal Mask and Numa Full Face Mask are substantially equivalent to the predicate devices.
Clinical Test
No clinical testing was performed; use of full face mask and nasal mask with CPAP or bilevel therapy is proven technology and is well accepted by the medical community.
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Conclusion
Substantial Equivalence Conclusion
The Viva Nasal Mask and Numa Full Face Mask are substantially equivalent to the predicate devices:
-they have similar indications for use;
- -they have similar technological characteristics to the predicate devices;
-they do not raise any new questions of safety or effectiveness;
-they are substantially equivalent to the predicate devices.